Back to resultsEffectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis
Primary Purpose
Calcaneal Apophysitis, Sever's Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Podoactiva cutom-made foot orthoses
Podoactiva heel lifts
Sponsored by
About this trial
This is an interventional treatment trial for Calcaneal Apophysitis
Eligibility Criteria
Inclusion Criteria:
- diagnosed radiologically with calcaneal osteochondritis
- diagnosed radiologically with calcaneal osteochondritis
- have signed informed consent
Exclusion Criteria:
- had suffered some trauma on the heel in the past 2 months
- had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
- had presented physical or neurological impairment
- were not interested
Sites / Locations
- Alejandro Jesús Almenar Arasanz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Custom-made foot orthoses
Heel Lifts
Arm Description
Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity. Treatment period of 12 weeks
Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity. Treatment period of 12 weeks
Outcomes
Primary Outcome Measures
Visual analogical scale (VAS)
Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS)
Algometry
Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention
Sport activity pain perception
Sever´s disease pain perception measured asking the following question: "Do you have pain at sport activity?", before and after intervention
Secondary Outcome Measures
Foot Posture Index (FPI)
values of Foot Posture Index (FPI) test in children with calcaneal apophysistis
lunge test values
values of lunge test in children with calcaneal apophysistis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03960086
Brief Title
Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis
Official Title
Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
February 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Podoactiva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.
It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneal Apophysitis, Sever's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Custom-made foot orthoses
Arm Type
Experimental
Arm Description
Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.
Treatment period of 12 weeks
Arm Title
Heel Lifts
Arm Type
Active Comparator
Arm Description
Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.
Treatment period of 12 weeks
Intervention Type
Other
Intervention Name(s)
Podoactiva cutom-made foot orthoses
Intervention Description
Children had to use the orthotics daily during the intervention period
Intervention Type
Other
Intervention Name(s)
Podoactiva heel lifts
Intervention Description
Children had to use the orthotics daily during the intervention period
Primary Outcome Measure Information:
Title
Visual analogical scale (VAS)
Description
Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS)
Time Frame
At baseine and after the intervention period
Title
Algometry
Description
Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention
Time Frame
At baseine and after the intervention period
Title
Sport activity pain perception
Description
Sever´s disease pain perception measured asking the following question: "Do you have pain at sport activity?", before and after intervention
Time Frame
At baseine and after the intervention period
Secondary Outcome Measure Information:
Title
Foot Posture Index (FPI)
Description
values of Foot Posture Index (FPI) test in children with calcaneal apophysistis
Time Frame
At baseline
Title
lunge test values
Description
values of lunge test in children with calcaneal apophysistis
Time Frame
At baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed radiologically with calcaneal osteochondritis
diagnosed radiologically with calcaneal osteochondritis
have signed informed consent
Exclusion Criteria:
had suffered some trauma on the heel in the past 2 months
had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
had presented physical or neurological impairment
were not interested
Facility Information:
Facility Name
Alejandro Jesús Almenar Arasanz
City
Zaragoza
ZIP/Postal Code
50001
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No, participants in this study were not adults and in the informed consent signed there was not indiated this statment
Learn more about this trial
Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis
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